SS: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

• Sponsor: Viela Bio (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04129164
• Collaborator: (none)
• Enrollment: 174
• Locations: 59
• Arms: 4
• Anticipated Duration (Months): 43.6
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

Condition or Disease	Intervention/Treatment	Phase
Sjögren's Syndrome	Drug: VIB4920; Drug: Placebo	Phase 2

Detailed Description

The study will enrol 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity defined by European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) >= 5; Population 2 will include participants with moderate to severe subjective symptoms defined by EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score >= 5 and residual stimulated salivary flow but with mild systemic disease activity defined by ESSDAI score < 5. This study will include 3 periods: screening (4 weeks), treatment period (40 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized at 1:1 ratio to receive intravenous (IV) dose of VIB4920 or placebo (Stage I). After completion of Stage I, participants randomized to VIB4920 in Stage I will receive placebo and participants randomized to placebo in Stage I will receive VIB4920 (Stage II). Participants who had study drug discontinuation will not be eligible for treatment during Stage II. All participants will be followed for at least 12 weeks after their last dose of study drug administration.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)
• Actual Study Start Date: Oct 16, 2019
• Anticipated Primary Completion Date: Feb 18, 2023
• Anticipated Study Completion Date: Jun 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIB4920 Dose 1 in Population 1 Participants in population 1 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.	Drug: VIB4920; Intravenous Dose 1.; Drug: Placebo; Intravenous dose matched to VIB4920.
Placebo Comparator: Placebo in Population 1 Participants in population 1 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.	Drug: VIB4920; Intravenous Dose 1.; Drug: Placebo; Intravenous dose matched to VIB4920.
Experimental: VIB4920 Dose 1 in Population 2 Participants in population 2 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.	Drug: VIB4920; Intravenous Dose 1.; Drug: Placebo; Intravenous dose matched to VIB4920.
Placebo Comparator: Placebo in Population 2 Participants in population 2 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.	Drug: VIB4920; Intravenous Dose 1.; Drug: Placebo; Intravenous dose matched to VIB4920.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Day 169 in Population 1 [Baseline (Day 1) and Day 169]

2. Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at Day 169 in Population 2 [Baseline (Day 1) and Day 169]

Secondary Outcome Measures

1. Change From Baseline in ESSPRI at Day 169 in Population 1 [Baseline (Day 1) and Day 169]

2. Percentage of Participants achieving ESSDAI [3] and ESSDAI [4] response in Population 1 [Baseline (Day 1) to Day 169]

3. Percentage of Participants achieving ESSPRI response in Population 2 [Baseline (Day 1) to Day 169]

4. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Day 169 in Populations 1 and 2 [Baseline (Day 1) and Day 169]

5. Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169 in Populations 1 and 2 [Baseline (Day 1) and Day 169]

6. Patient's Global Impression of Severity at Day 169 in Populations 1 and 2 [Day 169]

7. Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Populations 1 and 2 [From Baseline (Day 1) up to Day 365]

8. Number of participants With Adverse Events of Special Interest (AESIs) in Populations 1 and 2 [From Baseline (Day 1) up to Day 365]

9. Number of Participants With Abnormal Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs) Reported as TEAEs in Populations 1 and 2 [From Baseline (Day 1) up to Day 365]

10. Plasma Concentration of VIB4920 [Day 1 to Day 365]

11. Percentage of Participants With Positive Antibody Titer to VIB4920 in Populations 1 and 2 [Day 1 to Day 365]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.

• Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min (only for Population 2).

• Have an ESSDAI score of >= 5 at screening; (not including the peripheral nervous system, central nervous system, and pulmonary domains) (only for Population 1).

• Have an ESSPRI score of >= 5 at screening (only for Population 2).

• Have an ESSDAI score of < 5 at screening (only for Population 2).

• Positive for either anti-Ro autoantibodies or rheumatoid factor, or both at screening.

• Male and female participants who agree to follow protocol defined contraceptive methods.

• No active or untreated latent tuberculosis (TB).

Exclusion Criteria:

• Medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of signing the informed consent form (ICF).

• Risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.

• Concomitant polymyositis or dermatomyositis or systemic sclerosis.

• Active malignancy or history of malignancy, except in situ carcinoma of the cervix and cutaneous basal cell carcinoma.

• Hepatitis B, hepatitis C, or human immunodeficiency virus infection.

• More than one episode of herpes zoster and/or an opportunistic infection in the last 12 months.

• Active viral, bacterial, or other infections or history of more than 2 infections requiring intravenous antibiotics within 12 months prior to signing the ICF.

• Participants with corona virus disease 2019 (COVID-19) infection or who, in the judgment of the investigator, are at unacceptable risk of COVID-19 or its complications.

• A documented positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 2 weeks prior to randomization.

• Received live (attenuated) vaccine within the 4 weeks prior to ICF signature.

• Treated with any biologic B-cell-depleting therapy within 12 months or other B-cell targeting therapy < 3 months before randomization.

• Injectable corticosteroids (including intraarticular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization (only for Population 1).

• Treated with systemic corticosteroids for indications other than SS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) for more than a total of 2 weeks within 24 weeks prior to screening visit (only for Population 1).

• Received previous treatment with anti-CD40L compounds at any time before screening.

• Pregnant or lactating or planning to get pregnant during the duration of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Fullerton	California	United States	92835
2	Research site	Upland	California	United States	91786
3	Research Site	Lawrenceville	Georgia	United States	30046
4	Research Site	Kansas City	Kansas	United States	66160
5	Research Site	Baltimore	Maryland	United States	21224
6	Research Site	Wheaton	Maryland	United States	20902
7	Research Site	Boston	Massachusetts	United States	02111
8	Research Site	Lansing	Michigan	United States	48910
9	Research Site	Charlotte	North Carolina	United States	28204
10	Research Site	Durham	North Carolina	United States	27710
11	Research Site	Salisbury	North Carolina	United States	28144
12	Research Site	Wilmington	North Carolina	United States	28401
13	Research site	Duncansville	Pennsylvania	United States	16635
14	Research Site	Memphis	Tennessee	United States	38119
15	Research site	Dallas	Texas	United States	75231
16	Research Site	Houston	Texas	United States	77084
17	Research Site	Houston	Texas	United States	77089
18	Research Site	Bordeaux		France
19	Research Site	Brest		France
20	Research Site	Grenoble		France
21	Research Site	Paris Cedex 13		France
22	Research Site	Paris		France
23	Research Site	Strasbourg		France
24	Research Site	Budapest		Hungary	1097
25	Research Site	Debrecen		Hungary	4032
26	Research Site	Gyula		Hungary	5700
27	Research Site	Secunderabad	Andhra Pradesh	India	5000003
28	Research Site	Ahmedabad	Gujarat	India	380015
29	Research Site	Bangalore	Karnataka	India	560010
30	Research Site	Pune	Maharashtra	India	411013
31	Research Site	Pune	Maharshtra	India	411001
32	Research Site	Bhubaneswar	Odisha	India	751005
33	Research Site	Chennai	Tamil Nadu	India	600004
34	Research Site	Milano	Lambardia	Italy	20122
35	Research Site	Rome	Lazio	Italy	00161
36	Research Site	Brescia	Province Of Brescia	Italy	25123
37	Research Site	Perugia	Umbria	Italy	06129
38	Research Site	Pisa		Italy	56126
39	Research Site	Udine		Italy	33100
40	Research Site	Suwon si	Gyeonggi	Korea, Republic of	16499
41	Research Site	Incheon	Republic Of Korea	Korea, Republic of	21565
42	Research Site	Incheon	Republic Of Korea	Korea, Republic of	22332
43	Research Site	Seoul	Republic Of Korea	Korea, Republic of	06591
44	Research Site	Saltillo	Coahuila	Mexico	25000
45	Research Site	Guadalajara	Jalisco	Mexico	44650
46	Research Site	Guadalajara	Jalisco	Mexico	44690
47	Research Site	Ciudad de mexico		Mexico	06700
48	Research Site	Lima	San Martin De Porres	Peru	31
49	Research Site	Lima		Peru	1
50	Research Site	Lima		Peru	33
51	Research Site	Krakow		Poland	30-363
52	Research Site	Lublin		Poland	20-412
53	Research Site	Poznan		Poland	60-693
54	Research Site	Siedlce		Poland	08-110
55	Research Site	Warszawa		Poland	02-637
56	Research Site	Warszawa		Poland	02-691
57	Research Site	Wrocław		Poland	02-637
58	Research Site	Newcastle Upon Tyne		United Kingdom	NE1 4LP
59	Research Site	Truro		United Kingdom	TR13LJ

Sponsors and Collaborators

• Viela Bio

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viela Bio
• ClinicalTrials.gov Identifier: NCT04129164
• Other Study ID Numbers: VIB4920.P2.S2; 2019-002713-19
• First Posted: Oct 16, 2019
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Viela Bio: Sjögren's Syndrome; SS; VIB4920; MEDI4920
• Additional relevant MeSH terms: Sjogren's Syndrome; Syndrome

Study Results

No Results Posted as of Oct 1, 2021